Summary of Product Characteristics
last updated on the eMC:
23/06/2011
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 23/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 04-Apr-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| An Unlimited MA has now been granted, 3 yearly PSURs will be submitted.
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Updated on 27/07/2009 and displayed until 23/06/2011
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Reasons for adding or updating:
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Change due to harmonisation of SPC
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| Date of revision of text on the SPC: 24-Jun-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Type 1B harmonisation to update SPC sections 4.1 to 5.3. Sections 4.1 to 5.3 of the SPC have been updated in line with the originator.
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Updated on 05/09/2007 and displayed until 27/07/2009
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Reasons for adding or updating:
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